BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAGLEY STONE RETRIEVAL HELICAL BASKET

    MDR report key: 1910647 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04947
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF TIP DETACHED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT THE DEVICE BASKET, BASKET WIRES, AND BASKET TIP WERE ALL PRESENT AND ATTACHED. HOWEVER, A FRAGMENT OF THE DISTAL TIP OF THE OUTER SHEATH, MEASURING APPROXIMATELY 8MM, WAS FOUND TO BE DETACHED; THE DETACHED FRAGMENT WAS PRESENT WITH THE RETURN. THE DRIVE WIRE WAS ALSO FOUND TO BE KINKED. MOST LIKELY THE TEAR TO THE OUTER SHEATH AND KINKS ON THE DRIVE WIRE WERE CAUSED BY SOME ASPECT OF THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 10, 2010 THAT A BAGLEY STONE RETRIEVAL HELICAL BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TIP OF THE RETRIEVAL DEVICE "BROKE OFF" INSIDE THE PATIENT. THE DETACHED PORTION WAS RETRIEVED FROM THE PATIENT USING A DISPOSABLE GRASPER, AND THE PROCEDURE WAS COMPLETED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A BAGLEY STONE RETRIEVAL HELICAL BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT ID, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TIP OF THE RETRIEVAL DEVICE "BROKE OFF" INSIDE THE PATIENT. THE DETACHED PORTION WAS RETRIEVED FROM THE PATIENT USING A DISPOSABLE GRASPER, AND THE PROCEDURE WAS COMPLETED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAGLEY STONE RETRIEVAL HELICAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063401210 13806104

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention